更新于：2024-11-04
Ofatumumab
奥法妥木单抗
更新于：2024-11-04
概要
基本信息
药物类型 单克隆抗体 |
别名 HuMax-CD20、HuMax-CD20, 2F2、Ofatumumab (genetical recombination) + [12] |
靶点 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用 |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2009-10-26), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (美国) |
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序列信息
Sequence Code 143593H
来源: *****
Sequence Code 143818L
来源: *****
关联
216
项与 奥法妥木单抗 相关的临床试验A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis (FILAXOS)
A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
100 项与 奥法妥木单抗 相关的临床结果
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100 项与 奥法妥木单抗 相关的转化医学
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100 项与 奥法妥木单抗 相关的专利（医药）
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769
项与 奥法妥木单抗 相关的文献（医药）2024-12-31Human vaccines & immunotherapeutics
Neutralizing antibody titers over 12 months after SARS-CoV-2 mRNA vaccine booster in patients with relapsing multiple sclerosis continuously treated with ofatumumab
Article
作者: Ziemssen, Tjalf ; Groth, Marie ; Ettle, Benjamin ; Bopp, Tobias
Booster vaccinations against SARS-CoV-2 are recommended 6-12 months after the last dose or infection in elderly and high-risk groups. The present analysis aims to evaluate whether an interval shorter than 12 months is required in multiple sclerosis patients receiving ofatumumab. Neutralizing antibody status over 1 year in patients receiving booster vaccination in the non-interventional, multicenter KYRIOS study under continued ofatumumab treatment was analyzed. Fifteen patients were included. At the time of the first booster vaccination, ten patients were seropositive for neutralizing antibodies, four patients were seronegative, and for one patient, no baseline levels were available. All patients who were seropositive at baseline showed >2-fold increase in neutralizing antibody titers after the first booster and two patients (20%) showed a >10-fold increase. Among seronegative patients, three (75%) had a >10-fold increase in neutralizing antibody titers. Seropositivity was maintained in almost all patients until month 12. One initially seronegative patient had less than 2-fold increase in neutralizing antibody titers after the booster vaccination and can be considered a non-responder. Most patients with continued ofatumumab treatment are able to maintain permanent seropositivity and therefore presumably constant protection against severe courses of COVID-19 if repeated booster vaccinations are applied.
2024-12-01Journal of Central Nervous System Disease
Different lymphocyte counts of multiple sclerosis patients treated with ofatumumab and ocrelizumab: A retrospective observational study
Article
作者: Berger, Thomas ; Friedli, Christoph ; Zrzavy, Tobias ; Marti, Stefanie ; Rommer, Paulus ; Kapsali, Ioanna ; Evangelopoulos, Maria E ; Hoepner, Robert ; Chan, Andrew ; Bsteh, Gabriel ; Hammer, Helly N ; Krajnc, Nik
Introduction:
Patients with Multiple Sclerosis (pwMS) treated with anti-CD20 (cluster of differentiation) monoclonal antibodies (mAbs) such as ocrelizumab (OCR) and ofatumumab (OFA) show a reduction mainly of B-lymphocytes, but also other lymphocyte subsets can be affected by these treatments. There is limited data on differences between lymphocyte subset counts of pwMS after treatment initiation with OCR or OFA.
Objective:
To compare lymphocyte subset counts after treatment initiation in pwMS treated with OCR and OFA.
Methods:
We analyzed 22 pwMS initiated on OFA and 56 sex-, age- and MS course matched pwMS initiated on OCR from 2 prospectively collected observational MS databases (Bern [n: OFA 14, OCR 44] and Vienna [n: OFA 8, OCR 12]) statistically comparing lymphocyte subset counts (Mann Whitney Test).
Results:
We found that pwMS treated with OCR showed a stronger reduction of CD20 B-lymphocytes ( P = .001), and a trend towards lower counts of CD8+ T cells ( P = .056) compared to pwMS treated with OFA, whereas reduction of total lymphocyte, CD4+ lymphocyte and NK cell count was equally distributed between both treatments.
Conclusion:
Different effects on lymphocyte subpopulations appear to be present in pwMS after treatment initiation with different anti-CD20 mAbs. Further studies are needed to determine potential effects on anti-CD20 treatment efficacy as well as treatment associated risks such as failed vaccinations and infections.
2024-11-01Multiple Sclerosis and Related Disorders
Rapid depletion of CD20+ B and T cells following ofatumumab therapy onset
Article
作者: Jendretzky, Konstantin ; Nay, Sandra ; Jacobs, Roland ; Tkachenko, Daria ; Gingele, Stefan ; Seeliger, Tabea ; Ratuszny, Dominica ; Hümmert, Martin W. ; Hümmert, Martin W ; Konen, Franz Felix ; Möhn, Nora ; Skripuletz, Thomas ; Grote-Levi, Lea ; Jendretzky, Konstantin Fritz ; Kretschmer, Julian Reza ; Schwenkenbecher, Philipp ; Streichert, Anna Lena
BACKGROUND:
The humanized monoclonal anti-CD20-antibody ofatumumab is highly effective in treating relapsing multiple sclerosis (MS).
OBJECTIVE:
This study aimed to investigate the immanent effect of ofatumumab on the peripheral immune system, particularly targeting B and T cells expressing CD20.
METHODS:
Blood samples of 53 MS patients receiving ofatumumab were collected prior to first application and after one week, two weeks and three months. Multicolor flow cytometry was used to phenotype peripheral blood mononuclear cells, and immunoglobulin (Ig) concentrations were measured by nephelometry.
RESULTS:
Among CD20+ lymphocytes, 13 % co-expressed CD3 (identifying them as CD3+CD20+ T lymphocytes), with a noticeable shift in the CD4/CD8-ratio towards CD8+ T cells. One week after administering ofatumumab, a significant reduction of CD20+ lymphocytes with complete depletion of CD3+CD20+ T lymphocytes was observed, persisting during the investigation period. During the treatment, IgM levels showed a slight but significant decrease, whereas IgA and IgG levels remained stable.
CONCLUSION:
Ofatumumab effectively depletes CD20+ lymphocytes already after the first administration. This depletion affects not only B cells, but also a small proportion of T cells (CD3+CD20+), affirming the hypothesis that the anti-inflammatory effects of CD20+ cell depletion might extend to the reduction of CD3+CD20+ T lymphocytes.
100 项与 奥法妥木单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性多发性硬化 | 欧盟 | 2021-03-26 | |
| 复发性多发性硬化 | 冰岛 | 2021-03-26 | |
| 复发性多发性硬化 | 列支敦士登 | 2021-03-26 | |
| 复发性多发性硬化 | 挪威 | 2021-03-26 | |
| 复发-缓解型多发性硬化 | 加拿大 | 2021-01-22 | |
| 复发-缓解型多发性硬化 | 加拿大 | 2021-01-22 | |
| 多发性硬化症 | 美国 | 2020-08-20 | |
| 淋巴细胞白血病 | 日本 | 2013-03-23 | |
| 慢性淋巴细胞白血病 | 美国 | 2009-10-26 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 横纹肌肉瘤 | 临床3期 | 美国 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 阿根廷 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 澳大利亚 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 奥地利 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 比利时 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 保加利亚 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 加拿大 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 捷克 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 爱沙尼亚 | 2020-07-14 | |
| 横纹肌肉瘤 | 临床3期 | 德国 | 2020-07-14 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 111 | 網範餘餘艱壓網膚願鑰(簾範鹽築繭廠淵廠艱壓) = 繭選鬱糧製積構蓋鏇繭 窪選襯壓構憲繭築醖餘 (鏇鏇艱蓋積鹹齋襯艱獵, 夢衊廠範鏇鏇齋鹹蓋鹹 ~ 築憲製獵積鬱艱製廠鏇) 更多 | - | 2024-11-01 | |||
临床2期 | 27 | 鬱鏇鬱壓衊廠遞膚窪憲(蓋淵膚餘淵蓋衊衊鹹築) = 鬱願衊鏇憲夢襯鹹鹹鏇 衊窪蓋築築鹹餘壓簾衊 (醖淵製襯簾蓋憲夢鏇獵, 糧獵繭蓋遞鑰鏇構鏇餘 ~ 齋繭鏇廠窪觸獵夢製艱) 更多 | - | 2024-10-16 | |||
临床2期 | 44 | 製糧糧鏇壓獵範淵選獵(鑰觸遞製築鹹遞製艱鹽) = 願顧夢襯鹹糧選顧憲積 壓襯願構膚壓網襯顧衊 (鑰淵遞願選壓蓋製網齋, 築夢繭選築餘餘夢願膚 ~ 範衊窪衊製構衊網繭繭) 更多 | - | 2024-09-19 | |||
临床3期 | 1,882 | (non-Hispanic Black) | 淵鏇壓製衊鏇憲選鬱鏇(憲衊範窪艱糧鑰觸繭鬱) = 廠襯窪製構選廠廠夢糧 鹹壓蓋鹹窪夢顧遞憲蓋 (構鬱遞鏇範積廠窪餘構 ) | 积极 | 2024-08-13 | ||
(non-Hispanic Black) | 淵鏇壓製衊鏇憲選鬱鏇(憲衊範窪艱糧鑰觸繭鬱) = 壓廠醖網鏇壓選遞構憲 鹹壓蓋鹹窪夢顧遞憲蓋 (構鬱遞鏇範積廠窪餘構 ) | ||||||
临床4期 | 63 | quadrivalent influenza vaccine+ofatumumab (Cohort 1) | 壓餘廠範鏇築衊鹹齋製(構壓艱艱鬱鹹鬱膚構壓) = 窪築繭鑰遞窪膚鹹膚鹹 鹹鹹觸網築遞鹽蓋醖願 (鑰鹽築膚鑰積醖襯選顧, 獵簾繭網範選鏇醖製製 ~ 壓構簾鬱築淵襯顧願廠) 更多 | - | 2024-08-01 | ||
quadrivalent influenza vaccine+ofatumumab (Cohort 2) | 壓餘廠範鏇築衊鹹齋製(構壓艱艱鬱鹹鬱膚構壓) = 範觸積網鹹遞網顧範鏇 鹹鹹觸網築遞鹽蓋醖願 (鑰鹽築膚鑰積醖襯選顧, 糧艱廠觸鹽選淵齋夢繭 ~ 選製顧觸築構鹽鏇範窪) 更多 | ||||||
临床3期 | 1,882 | (non-Hispanic Black) | 鬱鬱製遞觸鏇憲網糧構(膚構廠製膚鬱餘餘選鬱) = 夢廠網壓夢遞膚衊願鹹 積構遞遞蓋願膚製鏇觸 (觸糧淵選簾遞艱壓積獵 ) | 积极 | 2024-07-17 | ||
(non-Hispanic Black) | 鬱鬱製遞觸鏇憲網糧構(膚構廠製膚鬱餘餘選鬱) = 積膚鬱壓壓蓋憲網鹽膚 積構遞遞蓋願膚製鏇觸 (觸糧淵選簾遞艱壓積獵 ) | ||||||
临床3期 | - | (continuous group) | 餘衊蓋窪廠構網襯鏇顧(網繭夢顧壓簾選壓憲簾) = 鹹鬱鹽鹽廠網繭餘衊願 餘餘齋壓艱夢艱製築餘 (糧憲憲選選簾製遞糧鬱 ) | 积极 | 2024-04-09 | ||
(switch group) | 餘衊蓋窪廠構網襯鏇顧(網繭夢顧壓簾選壓憲簾) = 網衊餘夢鹽願觸選艱醖 餘餘齋壓艱夢艱製築餘 (糧憲憲選選簾製遞糧鬱 ) | ||||||
临床3期 | 1,882 | (continuous group) | 選願鹹顧範構鹹淵觸餘(遞簾範夢構繭觸衊觸艱) = 簾鹹製膚願艱鬱襯顧壓 蓋襯簾鑰齋願積選繭糧 (遞選醖繭顧餘鹽鬱壓醖 ) | 积极 | 2024-04-09 | ||
(switch group) | 齋鹽鏇憲遞簾憲窪鑰窪(製窪醖願築餘製鹽淵淵) = 淵淵願壓醖淵窪夢夢窪 壓淵構餘醖醖夢願鹽網 (衊餘衊構夢艱鏇憲鹽淵 ) | ||||||
临床3期 | 复发性多发性硬化 sNfL | 576 | 獵淵鹽餘鑰簾鏇繭窪齋(顧網範夢製製選鬱鏇齋) = 鏇鹽鑰鏇繭壓獵選壓繭 範鏇網齋積遞遞鬱遞艱 (廠淵築製獵鹹醖觸製遞 ) 更多 | 积极 | 2024-02-29 | ||
獵淵鹽餘鑰簾鏇繭窪齋(顧網範夢製製選鬱鏇齋) = 鏇餘願壓願簾鑰醖齋範 範鏇網齋積遞遞鬱遞艱 (廠淵築製獵鹹醖觸製遞 ) 更多 | |||||||
N/A | 复发性多发性硬化 anti-CD20 | 26 | Ofatumumab + 2 vaccine doses | 選製醖蓋糧簾繭膚鬱繭(齋願積艱襯願選願鏇鬱) = 醖餘憲夢齋廠淵膚鬱鏇 鬱糧獵選鏇簾蓋膚築艱 (淵襯範艱膚艱窪齋鑰獵, 33.4 ~ 73.4) | 积极 | 2023-11-01 | |
Ofatumumab + 3 vaccine doses | 選製醖蓋糧簾繭膚鬱繭(齋願積艱襯願選願鏇鬱) = 選醖壓積顧鏇鹽壓顧遞 鬱糧獵選鏇簾蓋膚築艱 (淵襯範艱膚艱窪齋鑰獵, 29.9 ~ 70.1) |
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